Ace Aerosol Cloud Enhancer

Basic Information

• Brand Name: Ace Aerosol Cloud Enhancer
• Primary DI: 00349502203015
• Version / Model: 49502-203-01
• Company Name: Mylan Specialty L.P.
• Labeler DUNS: 194775557
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-10
• Public Version: 4
• Public Version Date: 2022-01-21
• Public Version Status: Update
• Public Device Record Key: a926b9b6-3690-426b-88f7-cf9723305146

Device Description

The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10226	Atomizer, non-ventilatory	A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30349502203016	GS1	Case	12	In Commercial Distribution
Primary	00349502203015	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]